Pharmacovigilance Specialist

Company Overview

Company details are not specified.

Job Summary

The Pharmacovigilance Specialist will play a crucial role in the monitoring and reporting of drug safety and adverse events. This position is expected to ensure the implementation and adherence to pharmacovigilance processes to maintain the safety of pharmaceutical products.

Responsibilities

• Oversee the pharmacovigilance processes and ensure compliance with regulations.
• Manage and maintain quality-related documentation and systems.
• Conduct regular audits of Pharmacovigilance (PV) systems and processes.
• Collaborate with relevant stakeholders to streamline PV activities and improve operational efficiency.
• Provide training and support to teams on PV-related topics.
• Analyze data related to drug safety and prepare reports for regulatory submissions.

Qualifications

• Education: Bachelor’s Degree in Life Sciences, Pharmacovigilance, or a Quality-related field.
• Experience:
  • 2-3 years of experience related to Global Product Operations (GPO) or Safety Processing Library (SPL).
  • Relevant experience in managing Quality Management Systems.
• Skills:
  • Strong understanding of PV processes and accompanying systems.
  • Excellent communication and organizational skills.
  • Ability to work collaboratively with cross-functional teams.
  • Familiarity with regulatory requirements in pharmacovigilance.

Preferred Skills

• Experience with data analysis and reporting tools.
• Advanced knowledge of quality assurance practices in the pharmaceutical industry.

Experience

• 2-3 years of experience in pharmacovigilance or related fields.

Environment

Typical work setting details are not specified.